The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
229
Toric accommodating lens implanted after cataract extraction
Accommodating lens implanted after cataract extraction
B&L Surgical
Bridgewater, New Jersey, United States
Percent Reduction in Absolute Cylinder
Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.
Time frame: 120 - 180 day postoperative visit
Lens Misalignment
This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.
Time frame: 120 - 180 day postoperative visit
Visual Acuity
Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)
Time frame: 120 - 180 day postoperative visit
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